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LZI — Device, Assistive Listening Class II

FDA Device Classification

Classification Details

Product Code
LZI
Device Class
Class II
Regulation Number
874.3320
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K043090phonic earEASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSDecember 23, 2004
K970974williams soundWILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPERMay 2, 1997
K970340bellabAIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIERMarch 26, 1997
K954748williams soundPOCKETALKER PRONovember 22, 1995
K952057national hearing aid distLISTENAIDER IIJune 21, 1995
K934805je liss and coHEARITFebruary 7, 1994
K904755krueger laboratoriesACOUSTIQ LISTENING DEVICEJanuary 29, 1991